Status:
ACTIVE_NOT_RECRUITING
Optical Coherence Tomography Versus Intravascular Ultrasound Guided Percutaneous Coronary Intervention
Lead Sponsor:
Seung-Jung Park
Collaborating Sponsors:
CardioVascular Research Foundation, Korea
Conditions:
Coronary Vessels
Eligibility:
All Genders
19+ years
Phase:
NA
Brief Summary
The primary aim of this study is to compare the clinical efficacy and safety of OCT-guided(optical coherence tomography (OCT)-guided) and IVUS-guided(Intravascular ultrasound (IVUS)-guided) strategies...
Eligibility Criteria
Inclusion
- Men or women at least 19 years of age
- Subjects with obstructive CAD undergoing PCI with contemporary DES or drug-coated balloons (only for in-stent restenosis) under intracoronary imaging guidance.
- The patient or guardian agrees to the study protocol and the schedule of clinical follow-up and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
Exclusion
- ST-elevation myocardial infarction
- Severe renal dysfunction (eGFR \<30 ml/min/1.73 m2 or serum creatinine level \>1.5 mg/dl), unless patient is on renal replacement therapy.
- Cardiogenic shock or decompensated heart failure with severe LV dysfunction (LVEF) \< 30%
- Life expectancy \< 1 year for any non-cardiac or cardiac causes
- Any lesion characteristics resulting in the expected inability to deliver the IVUS or OCT catheter to the lesion pre- and post-PCI (eg, moderate or severe vessel calcification or tortuosity)
- Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study
- Unwillingness or inability to comply with the procedures described in this protocol
Key Trial Info
Start Date :
April 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2027
Estimated Enrollment :
2008 Patients enrolled
Trial Details
Trial ID
NCT03394079
Start Date
April 12 2018
End Date
January 31 2027
Last Update
January 2 2026
Active Locations (9)
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1
Keimyung University Dongsan Medical Center
Daegu, South Korea
2
Konyang University Hospital
Daejeon, South Korea
3
Chonnam National University Hospital
Gwangju, South Korea
4
Pusan National University Hospital
Pusan, South Korea